Elecsys TSHRecalls & reported problems across all models

We found 4 models of Elecsys TSH by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 155 adverse event reports in the FDA's MAUDE database, received between Jul 12, 2018 and Sep 28, 2026 — classified as 3 injuries, 152 malfunctions.

The most frequently reported specific device problem is “High Test Results” (117 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Elecsys TSH problems

Elecsys TSH models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elecsys TSH 08443432190

  RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
  116 reports
• Elecsys TSH 07028091190

  RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
  25 reports
• Elecsys TSH 08443432214

  RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
  9 reports
• Elecsys TSH 08429324160

  RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
  5 reports

Recent Elecsys TSH adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917890 ↗
• MalfunctionMar 25, 2026High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH V2, ELECSYS CORTISOL II, AND ELECSYS FT4 IV ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CORTISOL ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY. THE SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES: TSH = 0.0171 MIU/L CORTISOL = < 1.50 NMOL/L WITH A DATA FLAG FT4 = < 0.500 PMOL/L WITH A DATA FLAG. THE SAMPLE REPEATED WITH THE FOLLOWING VALUES ON (B)(6) 2026: TSH = 3.23 MIU/L CORTISOL = 527 NMOL/L FT4 = 16.3 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689364 ↗
• InjuryJan 28, 2026High Test Results

  ROCHE DIAGNOSTICS RECEIVED AN ALLEGATION OF QUESTIONABLE HIGH RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH ELECSYS TSH V2 ON A COBAS 8000 E 801 MODULES. THE PATIENT WAS ALLEGEDLY TREATED WITH LEVOTHYROXINE AFTER MEASUREMENTS WERE PERFORMED WITH THE FIRST SAMPLE AND THE DOSAGE WAS ALLEGEDLY INCREASED AFTER MEASUREMENTS WERE PERFORMED WITH THE SECOND SAMPLE. THE FIRST SAMPLE REPORTEDLY RESULTED IN A TSH VALUE OF 3.74 MU/L WHEN TESTED WITH THE ROCHE METHOD ON THE FIRST E 801 ANALYZER. THE SAME SAMPLE WAS TESTED USING THE SIEMENS METHOD AND THE TSH RESULT WAS REPORTED TO BE 0.01 MU/L. THE SAMPLE WAS TESTED WITH THE ROCHE METHOD AFTER POLYETHYLENE GLYCOL (PEG) PRECIPITATION AND THE TSH RECOVERY WAS REPORTEDLY 1 %. THE SAMPLE WAS ALSO TESTED WITH THE ROCHE METHOD AFTER TREATMENT IN A HETEROPHILIC ANTIBODY BLOCKING TUBE AND IT WAS REPORTED THAT THERE WAS NO INDICATION OF HETEROPHILIC ANTIBODIES. AFTER THE FIRST SAMPLE MEASUREMENT, THE PATIENT WAS ASSUMED TO HAVE HYPOTHYROIDISM AND WAS REPORTEDLY TREATED WITH LEVOTHYROXINE. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE PATIENT WAS TREATED WITH LEVOTHYROXINE BASED ON THE TSH VALUE OBTAINED WITH THE ROCHE METHOD. ON (B)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201278 ↗
• MalfunctionJan 26, 2026High Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH V2 RESULTS FOR 4 PATIENT SAMPLES FROM COBAS E 801 ANALYTICAL UNITS. 2. PATIENT AGE RANGE: 4 YEARS, 3-ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 1-FEMALE, 1-MALE, 2-ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183971 ↗
• MalfunctionOct 23, 2025High Test Results; Output Problem; High Test Results; Output Problem

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH V2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PURE E 402 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369438 ↗
• MalfunctionJul 24, 2025Low Test Results; Low Readings; Non Reproducible Results; Low Test Results; Low Readings; Non Reproducible Results

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF A DISCREPANT RESULT FOR 1 PATIENT TESTED FOR ELECSYS TSH V2 ON A COBAS E 411 ANALYZER (DISK SYSTEM). 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587232 ↗
• MalfunctionJul 24, 2025High Test Results; High Test Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH V2 RESULTS FOR 3 PATIENTS TESTED ON COBAS E801 ANALYTICAL UNITS. 2. PATIENT AGE RANGE: 58 YEARS, ASKU 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: 2-MALE, 1-ASKU 5. PATIENT RACE BREAKDOWN: ASKU 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586692 ↗
• MalfunctionApr 29, 2025High Test Results; Chemical Problem; High Test Results; Chemical Problem

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH V2 RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925125 ↗
• MalfunctionJan 30, 2025False Positive Result; False Positive Result

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF NON-REPRODUCIBLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH ON A COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275038 ↗
• MalfunctionJan 30, 2025Non Reproducible Results; Non Reproducible Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS TSH ON A COBAS E 402 ANALYTICAL UNIT AND FOR 1 PATIENT ON A COBAS E411 DISK SYSTEM. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275034 ↗
• MalfunctionOct 21, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT TESTED FOR ELECSYS TSH ON A COBAS 8000 E 801 MODULE AND 1 PATIENT TESTED ON A COBAS 8000 E 602 MODULE. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501221 ↗
• InjurySep 11, 2024High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF ANALYZER ALARMS AND A QUESTIONABLE TSH ELECSYS RESULT FROM THE COBAS 6000 E 601 ANALYZER. THE INITIAL RESULT FOR THE PATIENT WAS 6.78 UIU/ML. THE PATIENT REPORTEDLY HAD A TSH RESULT FROM A DIFFERENT SAMPLE FROM JUST A FEW DAYS EARLIER THAT WAS NORMAL. NO SPECIFIC DATA WAS PROVIDED. THE NURSE ALLEGEDLY ASKED THE LABORATORY TO SEND THE PATIENT SAMPLE FOR CONFIRMATION TESTING. THE RESULT FROM A REFERENCE LABORATORY USING AN UNKNOWN METHODOLOGY WAS REPORTED TO BE 2.54 UIU/ML. THE PATIENT ALLEGEDLY HAD ALREADY BEEN TAKING A SYNTHROID DOSE OF 75 MCG/DAY. REPORTEDLY, WHEN THE PHYSICIAN RECEIVED THE INITIAL TSH RESULT OF 6.78 UIU/ML, THE DOSAGE WAS CHANGED TO 100 MCG/DAY AND THE PATIENT WAS DISCHARGED. THE CUSTOMER ALLEGED THE PATIENT REPORTED DIARRHEA BUT IT WAS UNKNOWN IF THIS WAS RELATED TO THE INCREASE IN MEDICATION DOSAGE. THE CUSTOMER ALLEGEDLY WAS NOT AWARE OF ANY ADVERSE CONSEQUENCE OF THE INCREASE IN DOSAGE FOR THE PATIENT. REPORTEDLY, THE CUSTOMER COMMUNICATED THE CORRECTED RESULT TO THE PATIENT'S PHYSICIAN AND REPORTEDLY THE PATIENT'S MEDICATION DOSAGE WAS BROUGHT BACK DOWN TO THE PRIOR DOSAGE. THERE WAS NO ALLEGATION OF AN ADVERSE IMPACT TO THE FETUS.

  Patient problems: Diarrhea

  MAUDE report 20189935 ↗
• MalfunctionApr 29, 2024High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH ELECSYS TSH RESULTS FOR 2 PATIENT SAMPLES. 2. PATIENT AGE RANGE: 1 PATIENT: 86 YEARS, OTHER: ASKU 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: 1 F, 1 ASKU 5. PATIENT RACE BREAKDOWN: ASKU 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203013 ↗
• MalfunctionApr 26, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TSH ELECSYS E2G 300 V2 (TSH) AND ELECSYS FT3 (FT3) ON A COBAS 8000 E 801 MODULE COMPARED TO THE ABBOTT METHOD. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 RESULTS. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192688 ↗
• MalfunctionMar 19, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH V2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO SSU. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLE. A NEW PATIENT SAMPLE WAS ALSO COLLECTED AFTER TWO HOURS. THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 8.12 MIU/ML. THE FIRST REPEAT RESULT OF THE INITIAL SAMPLE WAS >100 MIU/ML. THE SECOND REPEAT RESULT OF THE INITIAL SAMPLE WAS 122 MIU/ML. THIS REPEAT RESULT WAS DEEMED CORRECT.  THE RESULT OF THE NEW SAMPLE WAS 94.9 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928796 ↗

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